MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG BLOOD PUMP; VENTRICULAR (ASSIST) BYPASS

Model Number 102953

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Ischemia (1942); Renal Failure (2041); Multiple Organ Failure (3261); Heart Failure/Congestive Heart Failure (4446); Gastrointestinal Hemorrhage (4476)

Event Date 01/09/2024

Event Type  Injury  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.

Event Description

It was reported that the patient had a history of mildly reduced rv function pre-left ventricular assist device (lvad) implant and required a right ventricular assist device (rvad) on (b)(6) 2024 during the lvad implant procedure.The patient also had kidney failure and was on continuous renal replacement therapy (crrt) immediately post lvad implant.The patient did not respond to intravenous diuretic therapy in which renal function worsened with a creatinine of 2.8 milligrams per deciliter at the initiation of crrt.The patient had symptoms of decreased urine output and pressor requirements were increased.The renal dysfunction was not related to the device or therapy.Additionally, positive blood cultures were reported with 1 out of 2 blood cultures positive.A source of infection was not identified but the patient's white blood cells were 45 cells per microliter and the bacteria identified was enterococcus faecium.The patient was treated with 3 different intravenous antibiotics, flagyl (metronidazole), micafungin and zerbaxa (ceftolozane).Repeat blood cultures on (b)(6) 2024 and (b)(6) 2024 were negative.On (b)(6) 2024, the patient complained of worsening abdominal pain and their lactate was elevated to 8 millimoles per liter.The patient became encephalopathic and required re-intubation.Based on a computed tomography scan there was a concern for ischemic bowel.The patient was taken to the operating room for the ischemic bowel and ileocecectomy with ileostomy was performed.The patient also had a gastrointestinal bleed that began (b)(6) 2024.Anticoagulation medication was held starting on (b)(6) 2024.The bleeding was treated with packed red blood cells.An esophagogastroduodenoscopy on (b)(6) 2024 was negative for any active bleeding.Gastroenterology looked through the ostomy and saw evidence of ischemic ulceration which was the likely source of bleeding while on anticoagulation.The patient passed away on (b)(6) 2024 after care was withdrawn.The patient remained on the rvad until they passed as well.There were no lvad or rvad related issues that attributed to the patient¿s rv dysfunction and subsequent death.Related manufacturer reference number: 2916596-2024-01379.

• Brand Name: CENTRIMAG BLOOD PUMP
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer (Section G): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer Contact: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 18969983
• MDR Text Key: 338503895
• Report Number: 2916596-2024-01822
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 07640135140627
• UDI-Public: 07640135140627
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 102953
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 106 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White